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Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema

Information source: Dyax Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ACE Inhibitor Induced Angioedema

Intervention: ecallantide 60 mg (Drug); ecallantide 30 mg (Drug); ecallantide 10 mg (Drug); placebo (Drug); placebo match for 30 mg ecallantide arm (Drug); placebo match for 10 mg ecallantide arm (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Dyax Corp.

Summary

A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.

Clinical Details

Official title: Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Safety and Efficacy of Ecallantide

Secondary outcome: Time to Symptom Resolution Based on the Visual Analog Scale (VAS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females 18 years of age or older

- Must currently be on ACE inhibitor therapy and have received a dose within 36 hours

- Presenting with ACEIA of the head/neck region within 12 hours after onset

- All females must have a negative urine pregnancy test prior to administration of the

study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two years post-menopausal do not require a pregnancy test. Exclusion Criteria:

- Hypersensitivity to ecallantide

- Pregnancy or breast feeding

- Patients who have had angioedema and were not concurrently on an ACE inhibitor

- Patients exhibiting urticaria

- Patients who are intubated or who have a tracheostomy related to the current episode

of angioedema

- Opinion of the investigator that the patient would not be a good candidate

- Participation in another investigational study within 30 days prior to enrollment

Locations and Contacts

Er Med, Llc, Montgomery, Alabama 36106, United States

Arrowhead Regional Medical Center, Colton, California 92324, United States

University of California Los Angeles School of Medicine, Los Angeles, California 90095, United States

University of California San Diego Mecial Center, San Diego, California 92103, United States

Christiana Hospital, Department of Emergency Medicine, Newark, Delaware 19718, United States

Washington Hospital Center, Washington, District of Columbia 20010, United States

Tampa General Hospital, Tampa, Florida 33606, United States

Georgia Health Sciences University, Augusta, Georgia 30912, United States

DeKalb Medical, Decatur, Georgia 30033, United States

Mercy Hospital and Medical Center, Chicago, Illinois 60616, United States

University Consultants in Allergy and Immunology, Chicago, Illinois 60612, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Beaumont Hospital, Royal Oak, Royal Oak, Michigan 48073, United States

Beaumont Hospital, Troy, Troy, Michigan 48085, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Nevada Acess to Research and Education Study, Las Vegas, Nevada 89106, United States

Kings County Hospital Center, Brooklyn, New York 11203, United States

Winthrop University Hospital, Mineola, New York 11501, United States

Staten Island University Hospital, Staten Island, New York 10305, United States

East Carolina University, Greenville, North Carolina 27834, United States

Wake Forest Baptist Health, Winston-Salem, North Carolina 27157, United States

The MetroHealth System, Cleveland, Ohio 44109, United States

The Ohio State University Medical Center, Columbus, Ohio 43210, United States

University Hospital East, Columbus, Ohio 43205, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

University Medical Center Brackenridge, Austin, Texas 78701, United States

St Joseph Regional Health Center, Bryan, Texas 77802, United States

UT Southwestern Medical Center at Dallas, Dallas, Texas 75390, United States

Emergency Medicine Residency Program, Forth Worth, Texas 76104, United States

301 University Blvd., Galveston, Texas 77555, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Virginia Health System, Charlottesville, Virginia 22908, United States

Sentara Norfolk General Hospital, Norfolk, Virginia 23507, United States

Additional Information

Starting date: June 2011
Last updated: January 27, 2014

Page last updated: August 23, 2015

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